| Device |
implant, resorbable, for articular osteochondral repair |
| Definition |
This device is intended to repair knee joint surface cartilage or osteochondral lesions. |
| Physical State |
The device is a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects in traumatic and osteoarthritic joints. The implant is a porous, biodegradable scaffold, consisting of interconnected natural calcium carbonate (aragonite) derived from purified, inorganic coral exoskeleton. It has a cylindrical shape with tapered sides for press-fit implantation into bone. |
| Technical Method |
The device is implanted into a drilled hole through the defect and into the underlying bone. It gradually resorbs and is replaced by bone tissue. The material functions as a scaffold, encouraging filling of knee joint surface defects with new tissue. |
| Target Area |
Knee joint articular cartilage and underlying bone |
| Review Panel |
Orthopedic |
|---|
| Product Code | QRU |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
